An interventional study of Algosteril and Other Dressings: interface, hydrocellular, hydrofiber in Malignant Wound, sponsored by Institut Curie. Terminated at 12 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Institut Curie · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to compare of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode. This assessment will be made on adult patient with a malignant wound ≥ 10cm² who presents with a bleeding episode during a hospital consultation.
The primary endpoint is bleeding caused by the removal of a dressing applied during the first bleeding episode observed in the consultation.Effectiveness will be assessed by the resumption of bleeding during the following day's care, in order to respond to 2 care priorities: stopping the bleeding and avoiding its recurrence.The investigators propose a randomized study, with the choice between hemostatic (Algosteril®) or non-hemostatic (interface, hydrocellular, high-absorbency fiber dressing) being randomized and therefore not dependent on the wound or the care team.
In the proposed research, the investigators will evaluate pain on dressing removal, the stress that a bleeding episode can cause, and quality of life in relation to the malignant wound.
The investigators will observe the frequency of bleeding episodes over 6 months, the local care used and the medical management of these bleeding episodes.
In addition, the investigators will pay particular attention to the patient's entourage, as well as to the caregiver who will be carrying out the care, notably by measuring their stress levels during bleeding episodes.
Malignant wounds are the result of the oncogenic process. They may be caused by the initial tumor ulcerating on the skin, or by a secondary localization of the cancer (cutaneous metastasis). They may be external, cavitary or superficial.
The most frequent symptoms are bleeding, odour, pain and exudate. The appearance of these wounds can be impressive for the patient, family and caregivers if they are not used to dealing with this type of wound.
As these wounds are chronic, they need to be managed both in hospital and at home.
A retrospective study carried out at the Institut Curie showed that in 80% of cases, bleeding occurred at the time of treatment.
This bleeding is due to the friable nature of the tissues, which are highly vascularized as a result of tumor angiogenesis. They can therefore bleed easily when the dressing is removed.
The application of an alginate dressing, the only hemostatic dressing reimbursed in towns and cities (in France), seems to increase bleeding on dressing removal, compared with other, non-hemostatic products whose removal is less traumatic (interface, hydrocellular and hydrofiber).
The presence of minor bleeding is not negligible, as it appears to significantly increase the risk of more severe bleeding later on.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 4 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
control arm (Algostéril® hemostatic dressing): dressing used on the day of the bleeding episode in hospital
Other: Algosteril
experimental arm (non-haemostatic dressing): dressing used on the day of the bleeding episode in hospital
Other: Other Dressings: interface, hydrocellular, hydrofiber
hemostatic dressing
Non-haemostatic dressing
Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode
Bleeding rate on Day 1 of randomization, at the time of dressing change during a first bleeding episode. A bleed will be considered as a dressing removal for which the nurse had to: * use at least 2 packs of 5 compresses and * interrupt her care for \> 3 minutes to obtain hemostasis
Time frame: Day 1 after bleeding
Assess the pain at D1 when the dressing is removed
Visual Analog Pain Scale (scale from 0 to 10).A higher score indicates greater pain intensity
Time frame: Day 1 when the dressing is removed
Observe the frequency of bleeding over 6 months
Number of bleeding episodes over 6 months
Time frame: 6 months
Describe the bleeding characteristics and its immediate consequences;
Percent of type of bleeding (sheet or jet / pulsatile bleeding)
Time frame: 6 months
Describe local care at the time of a bleeding episode;
Type of the primary dressing used at the time of bleeding (percent)
Time frame: 6 months
Assess the stress of patients, family, and caregivers after a bleeding episode
Stress Visual Analogue Scale (scale from 0 (no stress) to 10 (stress maxi))
Time frame: 6 months
Wound quality of life
Wound Quality of Life Scale (5 suggested answers per question: not at all, a little, moderately, quite a bit and a lot)
Time frame: 5 months
Medical management of bleeding
Description of medical management related to bleeding: treatment initiated or modified; hemoglobin control; Transfusion; hemostatic radiotherapy; surgical or radiological management (embolization); sedation for the refractory symptom of bleeding in end-of-life patients
Time frame: 6 months
Assess the bleeding episodes according to the dressing subgroups defined in the nonhemostatic group (Interface and absorbent drainage dressing)
Description of induced bleeding on Day 1 according to the non-hemostatic dressing subgroup
Time frame: Day 1
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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